BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3349336 · Received September 16, 2013

    Report

    Report Number
    3004209178-2013-16256
    Event Type
    Malfunction
    Date Received
    September 16, 2013
    Date of Event
    January 1, 2013
    Report Date
    August 22, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8590-1, LOT# N121594, IMPLANTED:(B)(6) 2008, PRODUCT TYPE: ACCESSORY. PRODUCT ID: 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PUMP HAD NOT BEEN WORKING CORRECTLY SINCE (B)(6). PER THE REPORTER PREVIOUSLY THE PUMP WENT DRY BUT REGISTERED THERE WAS 7.6ML LEFT AND THE PATIENT WAS HAVING PAIN. PER THE PATIENT¿S FAMILY THE PUMP WAS DELIVERING MORPHINE AND ONE OTHER MEDICATION BUT SHE COULD NOT RECALL THE NAME OF THE SECOND ONE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT HAD NOT BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    464485 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00075 YR